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Clinical Trials |

Two-Year Follow-up of a 6-Month Randomized Trial of Atropine vs Patching for Treatment of Moderate Amblyopia in Children

The Pediatric Eye Disease Investigator Group*
Arch Ophthalmol. 2005;123(2):149-157. doi:10.1001/archopht.123.2.149.
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Published online

Objective  To compare patching and atropine sulfate as treatments for moderate amblyopia in children 18 months after completion of a 6-month randomized trial.

Methods  In a randomized, multicenter (47 sites) clinical trial, 419 children younger than 7 years with amblyopia (20/40 to 20/100 in the affected eye) were assigned to receive either patching or atropine eye drops for 6 months. Between 6 months and 2 years, treatment was at the discretion of the investigator.

Main Outcome Measure  Visual acuity in the amblyopic eye and sound eye after 2 years.

Results  At 2 years, visual acuity in the amblyopic eye improved from baseline a mean of 3.7 lines in the patching group and 3.6 lines in the atropine group. The difference in visual acuity between treatment groups was small: 0.01 logMAR (95% confidence interval, −0.02 to 0.04). In both treatment groups, the mean amblyopic eye acuity was approximately 20/32, 1.8 lines worse than the mean sound eye acuity, which was approximately 20/20.

Conclusions  Atropine or patching for 6 months followed by best clinical care until 2 years produced similar improvement of moderate amblyopia in children between 3 and 7 years of age at enrollment. However, on average the amblyopic eye acuity was still approximately 2 lines worse than the sound eye.

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Figure 2.

Cumulative distribution of amblyopic eye visual acuity scores at the 2-year outcome examination according to treatment group at the time of randomization.

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Figure 1.

Flowchart showing study completion in each treatment group. Of the 188 patients in the patching group with acuity tested per protocol, 139 completed the visit within the visit window of 100 and 108 weeks after randomization, 15 completed the visit early between 78 and less than 100 weeks, and 34 completed the visit late between more than 108 and 134 weeks. Of the 175 patients in the atropine sulfate group with acuity tested per protocol, 139 completed the visit within the visit window of 100 and 108 weeks after randomization, 14 completed the visit early between 78 and less than 100 weeks, and 22 completed the visit late between more than 108 and 134 weeks.

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